Application 206718

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	300MG;5MG	No	No
002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	300MG;7.5MG	No	No
003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	300MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;5MG	TABLET / ORAL	AA	RS	2017-03-31
A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;7.5MG	TABLET / ORAL	AA	RS	2017-03-31
A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;10MG	TABLET / ORAL	AA	RS	2017-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206718-001	AA
A206718-002	AA
A206718-003	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2017-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2017-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2017-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2017-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2017-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2017-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2017-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2017-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2017-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2017-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2017-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2017-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206718-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA		2017-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206718-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA		2017-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206718-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA		2017-03-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206718-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206718-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206718-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206718-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206718-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206718-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206718-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206718-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206718-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206718-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206718-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206718-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206718-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206718-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206718-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206718-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206718-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206718-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206718-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206718-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206718-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206718-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206718-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206718-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206718-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206718-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206718-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206718-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206718-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206718-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206718-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206718-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206718-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206718-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206718-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206718-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206718-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206718-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206718-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206718-001	AA	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	SpecGx LLC	d621b526-4d9a-48a9-9a3e-d29d6aea2f31	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206718 application number: ANDA206718 ndc (product): 0406-0378 ndc (product): 0406-0377 ndc (product): 0406-0376

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-0376	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0376	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0376	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0376	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0377	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0377	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0377	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0377	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0378	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0378	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0378	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current
0406-0378	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	SpecGx LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76047	ORIG	2023-11-02